Dysautonomia International

A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.

Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of the investigator) with history of migraine headaches of at least 6 months prior to the Screening Visit. - During the 28-day screening period, the participant (and their parent/caregiver, when applicable) must adequately complete the headache eDiary (≥23 of the 28 days) following the day of the Screening Visit. - During the 28-day screening period, the participant must have ≤14 headache days, of which at least 4 are migraine days as documented in the eDiary.

History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes (previously referred to as complicated migraine), such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, recurrent painful ophthalmic neuropathy, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration, e.g., >60 min). - History of moderate or severe head trauma or other neurological disorder or systemic medical disease that is, in the investigator's opinion, likely to affect the functions of the central nervous system. - Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania are excluded. - Any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or impair treatment compliance. Other inclusion and exclusion criteria may apply.

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm	Description	Assigned Intervention
Experimental Eptinezumab 300 mg	Participants will receive a single intravenous (IV) infusion of eptinezumab 300 mg (weight adjusted).	Drug: Eptinezumab Solution for infusion
Placebo Comparator Placebo	Participants will receive a single IV infusion of matching placebo to eptinezumab.	Drug: Placebo Solution for infusion
Experimental Eptinezumab 100 mg	Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).	Drug: Eptinezumab Solution for infusion

New England Institute for Clinical Research (NEICR) - Stamford
Stamford, Connecticut 06905-1206

Child Neurology Center (CNC) of Northwest Florida
Gulf Breeze, Florida 32561-4458

AGA Clinical Trials
Hialeah, Florida 33012-3407

University of South Florida (USF) - Tampa Campus
Tampa, Florida 33620

Akron Children's Hospital
Akron, Ohio 44308-1062

Cincinnati Children's Hospital Medical Center-Burnet Campus
Cincinnati, Ohio 45229-3026

Road Runner Research (RRR)
San Antonio, Texas 78249-3539

Children's Specialty Group (CSG)
Norfolk, Virginia 23507

Children's Wisconsin (Children's Hospital of Wisconsin)-Main Campus
Milwaukee, Wisconsin 53226

Email contact via H. Lundbeck A/S
+45 36301311
HQ_Medinfo@Lundbeck.com